Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM)

Completed

• Conditions: Lymphangioleiomyomatosis; Pulmonary Rehabilitation; LAM
• Interventions: Other: Pulmonary Rehabilitation

• Registration Number: NCT04184193
• Lead Sponsor: Schön Klinik Berchtesgadener Land

Brief Summary

Data from patients with the orphan disease of lymphangioleiomyomatosis (LAM) which performed a pulmonary Rehabilitation program will be analyzed retrospectively. Data will be taken from the internal data base of the reference Center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where These data were collected during clinical routine. Data will be included from the year 2000 until now. A retrospectively matched COPD cohort will be included for comparison.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-12-02
• Study Start: 2019-12-03
• Study First Posted: 2019-12-03
• Primary Completion: 2019-12-23
• Study Completion: 2019-12-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• confirmed diagnosis of Lymphangioleiomyomatosis
• performed a pulmonary Rehabilitation program at the reference center

Exclusion Criteria

• missing data
• repeated stay for pulmonary Rehabilitation at the reference center

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation	Pulmonary Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Change from baseline 6 Minute walk distance at week 4	baseline and week 4	the walked distance in meter will be the Primary outcome of the 6 Minute walk test
Change from baseline Quality of life at week 4	baseline and week 4	the physical and mental health component summary score from the Short Form 36 Health Questionnaire will be recorded. Score range from 0 to 100 with lower scores indicating worse impairment

Secondary Outcome Measures

Name	Time	Method
Change from baseline lung function at week 4	baseline and week 4	forced expiratory volume in 1 second and inspiratory vital capacity will be provided in Liter and percent predicted

Trial Locations

Locations (1)

Schoen Klinik Berchtesgadener Land; 🇩🇪 Schönau Am Königssee, Germany